Comparison of the Self-Expandable Intra-Annular Navitor Prosthesis with the Balloon-Expandable, Intra-Annular Sapien...

Background: The study aims to compare the short-term clinical outcomes of transcatheter aortic valve implantation (TAVI) with the novel self-expandable, intra-annular Navitor valve (NAV) and the balloon-expandable, intra-annular Sapien 3 Ultra valve (S3U). Methods: From a single-center TAVI database, patients receiving NAV and S3U were identified. We applied 1:2 propensity score matching for the selected variables (gender, age, aortic valve perimeter, area, diameter, mean aortic valve gradient, EuroScore2, coronary artery disease (CAD), previous stroke and previous pacemaker implantation), resulting in 153 patients. Results: Clinical outcomes at 30 days of 51 patients with NAV [mean age: 80.4 ± 6.7 years; 51% female; mean annulus diameter: 24.1 ± 1.40 mm; EuroScore2: 3.4 ± 3.1%] and 102 patients with S3U [mean age: 79.9 ± 6.5 years (p = 0.7); 51% female (p > 0.99); mean annulus diameter: 24.1 ± 1.4 mm (p > 0.99); EuroScore2: 3.2 ± 2.7 (p = 0.7)] were analyzed according to VARC-3 recommendations. Post-TAVI aortic valve mean (S3U: 11.0 [3-27] mmHg; NAV: 7 [3-15] mmHg; p < 0.001) and maximum (S3U: 22 [6-44] mmHg; NAV: 12 [5-28] mmHg; p < 0.001) gradients at discharge were significantly lower with NAV, whereas the effective orifice area (EOA) of the aortic valve measured significantly larger with NAV (S3U: 1.5 [0.8-3.8] cm²; NAV: 2.1 [0.9-3.5] cm²; p < 0.001). Rates of no to mild paravalvular regurgitation (PVL) were 92.1% after NAV and 91.2% after S3U implantation (p = 0.15), mild to moderate PVL were 2.0% after NAV vs. 2.9% after S3U (p = 0.1) and moderate PVL were 2% after NAV and 1% after S3U (p = 0.07). None of the patients had a severe regurgitation. Severe patient-prosthesis mismatch (PPM) occurred significantly less with NAV (S3U: 14.7%; NAV: 7.8%; p = 0.002). One (1%) non-disabling stroke occurred within the S3U group and none occurred within the NAV group (p = 0.1). Life-threatening (S3U: 2.9%; NAV= 1%; p > 0.99) and major (S3U: n = 2.9; NAV: 0%; p = 0.55) bleeding events were comparable between both groups. The incidence of major (S3U: 2.9%; NAV: 2.0%; p > 0.99) vascular complications and the need for permanent pacemaker implantation (S3U: 9.8%; NAV: 11.8%; p = 0.8) were comparable in both groups. The 30-day mortality rate was 0.7% [1 in NAV group (2%), none in S3U; p = 0.3]. Conclusions: In conclusion, at 30-day follow-up, the self-expanding intra-annular Navitor valve demonstrated excellent acute safety and superior early hemodynamic performance, characterized by significantly lower transvalvular gradients and lower rates of severe PPM compared to the balloon-expandable Sapien 3 Ultra. However, whether these acute hemodynamic advantages translate into superior long-term clinical outcomes remains to be determined in long-term follow-up studies.